Kornimate/medical-research-clean huggingface dataset:
telbivudine versus lamivudine in chinese adults with compensated chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study is being conducted to compare the effectiveness and safety of telbivudine (ldt) and lamivudine in chinese adults.


Eligibility criteria:
inclusion criteria: * documented clinical history compatible with chronic hepatitis b infection other protocol-defined inclusion criteria may apply exclusion criteria: * patient is pregnant or breastfeeding * patient is co-infected with hepatitis c virus (hcv), hepatitis d virus (hdv) or hiv * patient has previously received lamivudine or any investigational anti-hbv nucleoside or nucleotide analog other protocol-defined exclusion criteria may apply
using peripheral nerve stimulation (pns) to treat chronic post-surgical pain (cpsp) after knee surgery

Conditions: Injury; Nerve, Peripheral, Multiple; Chronic Post-Procedural Pain; Total Knee Arthroplasty; Surgery; Knee Injuries; Knee Pain Chronic; Postoperative Pain; Chronic Postoperative Pain

Summary: sprint pns system will be offered to patients with postoperative knee pain following primary unilateral total knee arthroplasty (tka) who meet eligibility criteria and consistent with established coverage policy. sprint pns system will be implanted for 60 days. at the discretion of the physician, the first lead may be placed to stimulate the nerve innervating the region of greatest pain. if pain is not adequately addressed by the first lead when assessed at 10 days, a second lead may be placed approximately 2 weeks following the initial lead placement.


Eligibility criteria:
inclusion criteria: * at least 21 years old * underwent a primary or revision unilateral tka * completed all choir questionnaires before and after tka surgery * persistent postsurgical knee pain ≥ 5 of 10 during ambulation as demonstrated on the choir assessment. * must meet the definition of chronic pain. 1. pain that continues or is expected to continue for longer than 3 months from its initial onset or 2. persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or 3. pain requiring opioid use beyond 30 days. exclusion criteria: * patients with a pre-operative history of moderate to high dose use of opioids (≥ 50 morphine milligram equivalents (mme) average per day) * patients taking opioids for reasons other than pain in knee that underwent tka * patients with arthrofibrosis or indicated for manipulation under anesthesia * bmi \>35 * uncontrolled diabetes mellitus types i or ii, indicated by an hba1c \>7.0% within the last 3 months * vulnerable population (e.g. pregnant women, prisoners, minors, or employees) * deep brain stimulation (dbs) system, an implanted active cardiac implant, or any other implantable neurostimulator whose stimulus current pathway may overlap the sprint stimulator's current pathway. * any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage in affected leg, pain caused by knee implant requiring revision, compromised immune system) as determined by the investigator * workers compensation

Keywords: chronic pain following left total knee arthroplasty chronic pain following right total knee arthroplasty
study evaluating the impact of a 13-valent pneumococcal conjugate vaccine on nasopharyngeal colonization

Conditions: Pneumococcal Infections

Summary: this study is designed to assess the impact of 13-valent pneumococcal conjugate vaccine (13vpnc) on nasopharyngeal colonization with streptococcus pneumoniae in healthy infants.


Eligibility criteria:
inclusion criteria: * healthy infants aged 2 months (42-98 days) at time of enrolment. * available for the entire study period and whose parent/legal guardian can be reached by telephone. exclusion criteria: * previous vaccination with licensed or investigational pneumococcal vaccine. * a previous anaphylactic reaction to any vaccine or vaccine-related component. * contraindication to vaccination with a pneumococcal conjugate vaccine.

Keywords: nasopharyngeal colonization streptococcus pneumoniae healthy infants vaccines pneumococcal conjugate vaccine
rct on lift versus modified parks technique versus two-stage seton

Conditions: Anal Fistula

Summary: lift is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. modified parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. placement of seton in the fistula track has been used for a long time and is still being currently used. drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula. this present randomized study aimed to compare lift, modified parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.


Eligibility criteria:
inclusion criteria: * adult patients of either sex aged less than 65 years presenting with complex anal fistula were included. complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females exclusion criteria: * patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula) * patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases. * patients on long-acting steroids or immunosuppressive drugs. * patients with fecal incontinence (fi) * patients with previous anorectal operations including surgery for previous anal fistula. * patients with asa score (american society of anesthesiologists) of iii and higher
multicenter study of antimicrobial resistance of gram-positive and gram-negative clinical strains to ceftaroline and other antimicrobials in russia

Conditions: Bacterial Skin Diseases

Summary: approximately 3,000 of clinically significant isolates of different species from respective respective sources in geographically distinct russian cities will be collected and tested on ceftaroline and other antimicrobials.


Eligibility criteria:
inclusion criteria: * isolates derived from patients' clinical material will be included in the study * isolates collected retro- and prospectively will be included in the study (from 01.01.2008 till 31.12.2012) * isolates, allocated of a clinical material of adult patients (\> 18 years), should make not less than 70 % from total number of included isolates) * all included isolates should be unique: only one isolate can be included in the study of each biological type from each patient * all isolates should correspond to clinic-laboratory criteria of the etiologic importance, i.e. should be derived from patients with infection symptoms from the corresponding clinical material * case report form (crf) (appendix 1) should be correctly completed for each isolate exclusion criteria: * esbl-producing representatives of enterobacteriaceae (esbl-extended-spectrum beta-lactamase) * isolates, arrived in the central laboratory contaminated or unviable

Keywords: ceftaroline, infection, capb, cap, absssi, cssti
dapagliflozin in type 1 diabetes

Conditions: Fasting Glucose; Glucose Excursion; Glycemic Control

Summary: dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked transporter 2 (sglt2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. the effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. due to its mechanism-of action it seems likely that also type 1 diabetic patients will benefit from dapagliflozin. the present study is focused on the effects of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic patients. participants will subsequently receive 10 milligrams of dapagliflozin and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over design. the effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose excursions).


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (duration of disease at least 5 years) * c-peptide concentration \< 0.2µg/l * male sex * aged 18 to 60 years * body mass index 20 - 25 kg/m2 * no measurable, clinically relevant ketonuria exclusion criteria: * insufficient venous status on both forearms * renal and/or hepatic insufficiency (including microalbuminuria and/or albumin/creatinin-ratio) * history of cancer * intake of medication and/or substances capable to influence insulin sensitivity within the last 3 months prior to study inclusion * alcohol- and/or drug abuse, nicotine consumption \> 5 cigarettes / 24h * brittle-diabetes * history of severe hypoglycemia, defined as the need for foreign assistance independent of actual blood glucose concentration measured * history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the participant to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.

Keywords: dapagliflozin fasting glucose postprandial glucose excursion euglycemic hyperinsulinemic clamp euglycemic oral glucose tolerance test
risk indicators in patients with ventricular fibrillation during acute myocardial infarction

Conditions: Acute Myocardial Infarction; Sudden Cardiac Death

Summary: sudden cardiac death is in most cases triggered by ischemia-related ventricular tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed countries. chronic elevation of indicators of coagulation activation has been found in patients with coronary heart disease , but a role of coagulation activation and proinflammatory state as a potential risk factor for ventricular fibrillation (vf) during acute myocardial infarction has not been investigated.

sudden cardiac death (scd) is in most cases triggered by ischemia-related ventricular arrhythmias and is responsible for 50% of the mortality from cardiovascular disease in developed countries (1). chronic elevation of indicators of coagulation activation and inflammation has been found in patients with coronary heart disease and may contribute to vasculatory disorders probably contributing to the development of arrhythmogenesis. however, the role of coagulation activation as a potential risk factor for ventricular fibrillation during acute myocardial infarction has not been investigated yet.

Eligibility criteria:
inclusion criteria: st-elevation myocardial infarction ventricular fibrillation during acute mi exclusion criteria: nstemi coagulation disorders, e.g.intake of coumadin

Keywords: acute myocardial infarction ventricular fibrillation coagulation inflammation
dose optimization of rivaroxaban combined with rifampicin

Conditions: Infections

Summary: the goal of this observational study is to learn about exposure levels of rivaroxaban at different doses in patients with prosthetic joint infection combined with the use of rifampicin. participants will be collected blood samples to determine rivaroxaban plasma concentration. the main question it aims to answer is to predict the dose adjustment of rivaroxaban combined with the use of rifampin.

this study is a prospective observational study and does not interfere with the normal clinical diagnosis and treatment process. in the case of patients with periprosthetic infection with or without rifampicin, the blood concentration of rivaroxaban was monitored, and the data were further predicted and analyzed by statistical tests and physiological pharmacokinetic models, and suggestions were made for dose optimization.

Eligibility criteria:
inclusion criteria: * patients aged\>18 years * the diagnosis was periprosthetic infection after joint replacement * orthopedic operations such as revision of artificial joints, removal of prostheses, debridement, etc. for the treatment of periprosthetic infection * rivaroxaban was used to prevent deep vein thrombosis after operation. exclusion criteria: * patients allergic to any excipient in rivaroxaban, rifampicin or tablets * patients with clinically significant active bleeding * patients with significant risk of bleeding * patients with liver disease with coagulation abnormalities and clinical-related bleeding risk, including patients with cirrhosis who reached child pugh c grade * pregnant women and breastfeeding women * patients taking combined drugs affecting rivaroxaban metabolism * patients who were unable or unwilling to cooperate with the study (such as mental or memory disorders) * patients discontinued without meeting study target days * patients with severe renal insufficiency (creatinine clearance rate \< 30ml / min)

Keywords: periprosthetic infection rivaroxaban
sleepiness and brain function: the effect of armodafinil in shift work sleep disorder

Conditions: Shift Work Sleep Disorder

Summary: the investigators hypothesize that in patients with shift work sleep disorder, armodafinil will specifically increase brain activity in the frontal cortex parallel with improvements in deficits of fundamental mechanisms of attention.

the current protocol will utilize a paradigm which is well suited to examine frontal attentional neuronal mechanisms by eliciting event related potential components known to reflect automatic stimulus detection as well as involuntary and voluntary attentional processes. the that end the proposed research has two specific aims. 1) identify what areas of the frontal lobe and corresponding cognitive functions are impacted by excessive sleepiness in shift work sleep disorder and 2) identify specific brain areas affected by armodafinil and their role in improvement of fundamental attentional processes using a complex cognitive task targeting attentional control.

Eligibility criteria:
inclusion criteria: * night shift workers with and without shift work sleep disorder. exclusion criteria: * secondary condition to shift work sleep disorder.
validation of a computerized triage algorithm for ophthalmic emergencies

Conditions: Emergencies

Summary: the investigators conceived a computerized interactive tool for emergency triage, based on a patient's symptoms, medical history and background. using this tool, the patient (alone or helped by a nurse / supporting person) presenting to an ophthalmologic er, should be able to detect and prioritize his most urgent symptoms (a,b), in opposition to less urgent (c) or non urgent symptoms (d). to test the validity of this tool, each patient presenting at the rothschild foundation er (paris, france) with an ophthalmological problem should be included and sorted by the algorithm before the medical consultation. neither the patient nor the practitioner are aware of the scoring (a,b,c,d) defined by the algorithm. the practitioner should then give his own emergency scoring (a,b,c,d) after patient examination. a total of 1000 patients is expected.


Eligibility criteria:
inclusion criteria: * patients attending the emergency room for ophthalmologic concerns exclusion criteria: -

Keywords: triage algorithms emergencies eyes emergencies ophtalmology
autologous conditioned plasma (acp) intra-articular (ia) injections for knee osteoarthritis (oa)

Conditions: Osteoarthritis

Summary: this study is primarily investigating the effectiveness of autologous conditioned plasma (acp) intra-articular (ia) in patients with osteoarthritis (oa) in the knee.

this study is a prospective, multi center randomized double blind, two arm study. 90 subjects will be randomized to receive injections of either autologous conditioned plasma intra-articular or the control.

Eligibility criteria:
inclusion criteria: 1. the subject is 18 to 70 years of age. 2. the subject presents with complaints of continued pain of primary knee for at least 6 weeks. 3. the subject has documented radiographs evidence of osteoarthritis (oa) in the tibio-femoral or patella-femoral compartment of the target knee (kellgren-lawrence grades ii-iii), using radiographs performed within 24 weeks of screening. 4. the subject has a womac pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities exclusion criteria: 1. grade i and iv on the knee kellgren-lawrence grading scale 2. subject has clinically 3+ effusion of the target knee (stroke test grading system). 3. subject has significant (\> 10⁰) valgus or varus deformities as evidenced by standard of care x-ray. 4. subject has had systemic or ia injection of corticosteroids in any joint within three months prior to screening. 5. viscosupplementation in any joint in the past six months. 6. subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin). 7. subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months 8. subject has inflammatory disease of either knee other than oa. 9. subject with underlying medical conditions that could interfere with the evaluation of the outcome. 10. subject with positive pregnancy test, or breast feeding. 11. subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months. 12. subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 13. subject has rheumatoid arthritis or gout 14. subject has a history of or a current infection at the affected joint. 15. subject with plans to undergo any elective orthopedic surgery in the next 12 months. 16. subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.
efficacy study of intramuscular or intracoronary injection of autologous bone marrow cells to treat scarred myocardium

Conditions: Myocardial Infarct; Bone Marrow Cells

Summary: the purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas.


Eligibility criteria:
inclusion criteria: * patients undergoing elective cabg * chronic irreversible myocardial scar * coronary vessel supplying the scar must be amenable to bypass grafting exclusion criteria: * significant valvular heart diseases * major organ failures, eg. heart, liver, renal etc * pre-existing bone marrow conditions
micropulsed laser trabeculoplasty using different parameters

Conditions: Glaucoma, Open-Angle

Summary: this randomized, double blinded, clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma. group one is treated with 1500 mw of power, group two with 1000 mw. the other settings (300 micron of diameter, 300 ms of duration, 15% duty cycle) are the same for both groups, and the laser is applied for 360°. the main outcome is to evaluate the iop (intraocular pressure) lowering effects of both treatments and the safety on the corneal endothelium.

this study is a randomized, double blinded, clinical trial. eligibility criteria are: primary open angle glaucoma, pigmentary glaucoma and pseudoexfoliation glaucoma. exclusion criteria are: secondary glaucoma, previous glaucoma surgery (not including cataract surgery as a glaucoma surgery), uncooperative patients, corneal endothelial diseases (such as fuchs dystrophy or cornea guttata) and severely decompensated glaucoma. both eyes of the patient are treated: each eye is allocated in a group using the closed envelopes method. both the patient and the surgeon who performs the post laser examinations are not aware of the group allocation. the exams required before the trabeculoplasty are: best corrected visual acuity, iop measurement, specular microscopy with corneal central thickness. the iop is measured an hour after mlt (micropulsed laser trabeculoplasty), then on day one, at one month, at three months and six months. best corrected visual acuity and specular microscopy are repeated at three months. expected outcomes: to compare the iop lowering effects between group one and two and to assess the safety of the procedure on the corneal endothelium. secondary outcomes: decrease the number of glaucoma medications applied by the patients.

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma * pigmentary glaucoma * pseudoexfoliative glaucoma exclusion criteria: * secondary glaucoma * previous glaucoma surgery * severely decompensated glaucoma * corneal endothelial disease
study of current practice which compare the rate of prostate cancer by using 2 kind of transrectal biopsies: 3 by irm-echography image fusion and 12 systematized guided echographies.

Conditions: Prostate Cancer

Summary: the purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by irm, guided by a fusion of mri and ultrasound- images with the koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.

the act of current practice evaluated by this research is the act of prostate biopsies : the patient will have to undergo 12 systematized transrectal echography guided biopsies of the prostate and 3 additional biopsies targeted on the suspicious lesion detected with mri, which are both done in current practice. * a first operator is not informed of the location of the target. he will perform a series of 12 systematic transrectal ultrasound-guided biopsies of the prostate. * immediately after the second operator will perform 3 additional targeted biopsies on the suspicious image detected by irm, guided by a fusion of mri and ultrasound- images with the koelis ® system act added by the research: using a fusion of mri - ultrasound images software system (koelis ®).

Eligibility criteria:
inclusion criteria: * patient from 45 to 75 years old; * serum level of psa \> 4,0 ng / ml; * multiparametric prostate irm, performed before inclusion and which confirm the diagnosis of suspected target; * no opposition of the patient notified in the medical record * patient member in a national insurance scheme. exclusion criteria: * previous prostate biopsy; * suspicious digital rectal examination; * serum psa \> 20,0 ng / ml; * treatment with 5 alpha reductase inhibitor during the last 3 months; * untreated urinary infection

Keywords: cancer prostate psa biopsies ultrasound mri fusion of images